First-line cetuximab with FOLFOX or FOLFIRI every 2 weeks in KRAS wild-type metastatic colorectal cancer: phase II APEC study — ASN Events
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First-line cetuximab with FOLFOX or FOLFIRI every 2 weeks in KRAS wild-type metastatic colorectal cancer: phase II APEC study (#17)

Timothy Price 1 , Ann-Lii Cheng 2 , Gerardo Cornelio 3 , Lin Shen 4 5 , Tsai-Sheng Yang 6 , Ik-Jou Chung 7 , Guang-Hai Dai 8 , Jen-Kou Lin 9 , Atul Sharma 10 , Kun-Huei Yeh 2 , Brigette Ma 11 , Adel Zaatar 12 , Zhongzhen Guan 13 , Nehal Masood 14 , Vichien Srimuninnimit 15 16 , Thomas Yau 17 , Barbara Sarholz 18 , Robert Lim 19
  1. Queen Elizabeth Hospital, Woodville, SA, Australia
  2. National Taiwan University Hospital, Taipei, Taiwan
  3. San Juan de Dios Hospital, Pasay City, Philippines
  4. Beijing Cancer Hospital, Beijing, China
  5. Beijing Cancer Hospital, Beijing, China
  6. Chang Gung Memorial Hospital-LinKou, Taoyuan, Taiwan
  7. Chonnam National University Hwasun Hospital, Hwasun-eup, South Korea
  8. The General Hospital of the People's Liberation Army, Beijing, China
  9. Taipei Veterans General Hospital, Taipei, Taiwan
  10. All India Institute of Medical Sciences, New Delhi, India
  11. Prince of Wales Hospital, Sha Tin, Hong Kong
  12. Mount Miriam Cancer Hospital, Penang, Malaysia
  13. Sun Yat-sen University Cancer Center, Guangzhou, China
  14. The Aga Khan University & Hospital, Karachi, Pakistan
  15. Siriraj hospital, Bangkok, Thailand
  16. Siriraj hospital, Bangkok, Thailand
  17. Queen Mary Hospital, Hong Kong
  18. Merck KGaA, Darmstadt, Germany
  19. National University Hospital, Singapore

Background: Randomized studies have shown that the addition of weekly cetuximab to FOLFOX or FOLFIRI improves clinical outcome in the first-line treatment of patients with KRAS wild-type metastatic colorectal cancer (mCRC). This Asia-Pacific multicenter non-randomized phase II study investigated the efficacy and safety of both FOLFOX and FOLFIRI in combination with every 2 weeks cetuximab as first-line therapy in patients with KRAS wild-type mCRC.

Methods: Eligible patients received every 2 weeks cetuximab (day 1, 500 mg/m2 every 14 days) with, based on investigator’s choice, either FOLFOX or FOLFIRI. Study treatment was continued until disease progression, the occurrence of unacceptable toxicity or consent withdrawal. The primary endpoint was tumor response; assessed radiologically (RECIST 1.0) every 8 weeks.

Results: ITT=289 patients; 65.1% received FOLFOX/cetuximab and 34.9% FOLFIRI/cetuximab. Baseline characteristics were generally well balanced. However, leukocyte count >10000/mm3 was more frequent (16.5% vs 7.9%) and prior adjuvant treatment less frequent (21.3% vs 46.5%) in patients receiving FOLFOX/cetuximab. A best overall RR (complete + partial) of 58.8% and a mPFS time of 11.1 months were observed in the combined ITT population. 70.9% of patients showed ≥20% reduction in tumor diameter at 8 weeks from baseline. A post-hoc analysis showed a mPFS time of 12.7 months for this group. The overall R0 resection rate in the ITT population was 10.0%. Survival data are not yet mature. Cetuximab dose intensity was >80% in 77.7% of patients in the FOLFOX/cetuximab group and 74.3% of patients in the FOLFIRI/cetuximab group. The most frequent grade 3/4 adverse events (reported for >10% of patients in either arm) were neutropenia, diarrhea, hypokalemia, neuropathy (FOLFOX/cetuximab group only) and skin reactions.

Conclusions: Efficacy and safety profiles of every 2 weeks cetuximab combined with FOLFOX or FOLFIRI were similar to those reported for either chemotherapy plus weekly cetuximab in pivotal studies.